Current Openings
Document Control/QA Specialist (part-time)
Job ID#: 55068
- Coordinate the Document Control System and process using MasterControl Document
- Management System. Maintain and improve the flow of documents through the system
- Assist with writing procedures for the Document Control process (e.g., Document Processing & Approval Process)
- Assist with creating and executing training on the MasterControl Document System
- Assist with writing, editing, and formatting documents and forms needed for the Quality Management System
- Review Quality System records and procedures for completeness, accuracy, consistency in content, format, and approvals
- Maintain Device History File Index. Review, file, and perform internal audits of Design History File documents for conformance to internal procedures
- Assist with configuration of MasterControl System for maintenance and retention of Design History Files
- Create reports and track status of documents
- Guide cross-functional teams in good documentation practices, document formatting and structure
- Perform filing, scanning, copying and electronic notification and distribution of released documentation
POSITION QUALIFICATIONS/REQUIREMENTS
- 2-5 years’ experience in documentation practices in an FDA-regulated environment
- Ability to demonstrate initiative. Ability to plan and organize work in an efficient manner, and work well under time constraints
- Proficient with Microsoft Windows desktop applications (Word, Excel, PowerPoint). Helpful to have skills with Adobe Acrobat and Visio. Excellent grammatical and proofreading skills with exceptional attention to detail
- Experience with electronic document management (MasterControl preferred)
- Application of good writing and oral communication skills
- Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice or format is required
- Ability to work with limited supervision
- Proven ability to multi-task and handle changing priorities as needed in a fast paced environment
Please email or fax your resume or curriculum vitae to us at the address below. Be sure to specify job reference ID# 55068 in the subject of the message.
Email: jobs@astutemedical.com
Fax: (858) 882-0449
Address:
Human Resources - Astute Medical
3550 General Atomics Court
MS 02/620, San Diego, CA 92121
